Evaluation of the Efficacy of OMK2 in Recovering Corneal Neural Damage in Patients With Diabetes

This will be a single-centre, randomized, pilot study. 30 patients with diabetes who previously had received Argon laser photocoagulation will be enrolled. These patients will receive corneal esthesiometry and will be divided in those with esthesiometry < 45 mm [6] (clinically detectable corneal neuropathy, CDCN) and not (NCDCN).

Patients will be randomized to the two treatment arms: 20 patients will be treated with active treatment (OMK2) and 10 patients will be treated with placebo (lubricant eye drops) given three times daily (8 am, 2 pm, 8 pm) for 18 months. Stratification for (1) CDCN, (2) duration of the disease, and (3) insulin-dependent diabetes will be adopted.

The randomization will be operator-masked.

Inclusion criteria

• At least 18 years old
• Type 1 or type 2 diabetic patients who received Argon Laser Photocoagulation

Exclusion criteria

• Neuropathy of any other cause than diabetes
• A history of conditions known to affect corneal sensitivity
• Coexisting other corneal diseases
• Autoimmune diseases
• Sjogren syndrome
• History of corneal trauma
• Contact lenses users
• Patients needing eye surgery or who received eye surgery at least 180 days before study beginning.
• contraindications to the use of any active substances and/or excipients
• pregnant and lactating women
• pediatric patients or adolescents under 18 years